Sunosi (solriamfetol) / Jazz, SK Bio, Uniphar, Axsome Therap, Pharmanovia - LARVOL DELTA

Solriamfetol initiated for residual sleepiness is not altering continuous positive airway pressure (CPAP) adherence in patients with obstructive sleep apnea (OSA): A French nationwide exhaustive database analysis (ERS 2026) - "Adherence to CPAP primary treatment of OSA is maintained after solriamfetol initiation."

Adherence • Clinical • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Real world observational registry study evaluting efficacy and safety of Solriamfetol, a wake-promoting agent, for the treatment of OSA patients with EDS (ChiCTR) - P4 | N=400 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P4 trial • Real-world evidence • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

SOLRIAMFETOL FOR THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OSA: POST HOC ANALYSIS OF EPWORTH SLEEPINESS SCALE ITEMS (CHEST 2026) - No abstract available

Retrospective data • Excessive Daytime Sleepiness • Narcolepsy • Obstructive Sleep Apnea • Sleep Disorder

Development of Narcolepsy Type 1 Following COVID-19 Infection in a Patient Previously Diagnosed With Idiopathic Hypersomnia: A Case Report. (PubMed, Cureus) - "Symptoms were refractory to multiple stimulant and antidepressant regimens but responded well to sodium oxybate in combination with solriamfetol, resulting in the resolution of EDS and cataplexy. This case highlights a possible temporal association between COVID-19 infection and the subsequent development of narcolepsy type 1 and underscores the importance of clinical judgment when objective diagnostic testing is inconclusive."

Journal • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Immunology • Infectious Disease • Narcolepsy • Novel Coronavirus Disease • Obstructive Sleep Apnea • Pediatrics • Respiratory Diseases • Sleep Disorder

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD (clinicaltrials.gov) - P3 | N=300 | Enrolling by invitation | Sponsor: Axsome Therapeutics, Inc.

New P3 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Pharmacotherapy in obstructive sleep apnoea: a clinical guide. (PubMed, Sleep Breath) - "This review provides a practical, endotype-aligned summary of pharmacologic options for the management of OSA."

Journal • Review • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Recent Advances and Emerging Pharmacotherapeutic Approaches for Central Hypersomnolence Disorders. (PubMed, Clin Pharmacol) - "In addition, oveporexton, an orexin receptor 2 agonist (OX2R) will be discussed as it marks an important first step in directly counteracting the pathology behind narcolepsy with cataplexy and has completed Phase 2 trials with Phase 3 underway. Early clinical data is promising; however, its long term efficacy and safety data is insufficient to garner US Food & Drug Administration approval, though additional trials are ongoing in narcolepsy with cataplexy, and non-orexin deficient central hypersomnolence disorders as well. Regardless, new drug developments may lead expanded treatment options and may have the potential to decrease or potentially eliminate the need for polypharmacy in the treatment algorithm for narcolepsy and idiopathic hypersomnia."

Journal • Review • Cataplexy • CNS Disorders • Narcolepsy • Psychiatry • Sleep Disorder

A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder (clinicaltrials.gov) - P3 | N=236 | Enrolling by invitation | Sponsor: Axsome Therapeutics, Inc. | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Binge Eating Disorder • CNS Disorders

ENGAGE: Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Axsome Therapeutics, Inc. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Binge Eating Disorder • CNS Disorders

A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD (clinicaltrials.gov) - P3 | N=468 | Recruiting | Sponsor: Axsome Therapeutics, Inc.

New P3 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHD (clinicaltrials.gov) - P3 | N=468 | Recruiting | Sponsor: Axsome Therapeutics, Inc.

New P3 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Post Hoc Analysis of Solriamfetol Efficacy in Obstructive Sleep Apnea Patients with Excessive Daytime Sleepiness Stratified by Disease Severity. (PubMed, Adv Ther) - P3 | "Solriamfetol showed good efficacy and tolerability regardless of OSA severity among Chinese OSA participants with EDS."

Clinical • Journal • Retrospective data • Cardiovascular • Excessive Daytime Sleepiness • Hypertension • Infectious Disease • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Axsome Therapeutics…announced that the first patient has been dosed in the FOCUS-2 Phase 3 trial evaluating solriamfetol as a treatment for children with attention deficit hyperactivity disorder (ADHD) (GlobeNewswire) - "FOCUS-2 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol in children aged 6 to less than 12 years with ADHD. Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of two doses of solriamfetol or placebo for 6 weeks."

Trial status • Attention Deficit Hyperactivity Disorder

Axsome Therapeutics Initiates FOCUS-3 Phase 3 Trial of Solriamfetol in Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) (Yahoo Finance) - "FOCUS-3 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol in adolescents aged 12 to less than 18 years with ADHD. Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of two doses of solriamfetol or placebo for 6 weeks."

Trial status • Attention Deficit Hyperactivity Disorder

Asymmetric α-amination of aldehydes at low catalytic loading: application to the synthesis of solriamfetol and nateglinide. (PubMed, Org Biomol Chem) - "This method exhibits a broad substrate scope, affording products in up to 96% yield and 94% ee. This scalable methodology is applied to the concise asymmetric synthesis of solriamfetol and nateglinide."

Journal

Axsome Therapeutics…announced presentations of new data on AXS-12 and solriamfetol at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 14-17, 2026... (GlobeNewswire)

Clinical data • Narcolepsy • Sleep Disorder

Sarcoidosis and Obstructive Sleep Apnoea: An Intriguing Relationship. (PubMed, Open Respir Med J) - "Despite increasing recognition, current evidence is limited by small sample sizes, heterogeneous diagnostic methods, and confounding effects of corticosteroid therapy. Future studies should clarify pathophysiological mechanisms, evaluate the impact of OSA treatment on sarcoidosis outcomes, and investigate wake-promoting agents such as solriamfetol and pitolisant as potential adjunctive therapies in patients with residual EDS."

Journal • Review • CNS Disorders • Excessive Daytime Sleepiness • Fatigue • Immunology • Inflammation • Myositis • Obesity • Obstructive Sleep Apnea • Pulmonary Disease • Respiratory Diseases • Sarcoidosis • Sleep Apnea • Sleep Disorder

Pharmacological treatment of obstructive sleep apnea syndrome (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "Until recently, pharmacological management was limited to nasal decongestants for rhinitis exacerbation and modafinil for daytime sleepiness...This review summarizes recent advances in OSAS drug therapy, primarily based on randomized clinical trials, with a focus on agents such as semaglutide, tirzepatide, atomoxetine-oxybutynin, solriamfetol, sultiame, and acetazolamide, as well as established drugs. Further research with long-term follow-up and consideration of OSAS endotypes and drug side effects is needed. The importance of combining different therapeutic approaches for OSAS is emphasized."

Clinical • Journal • Inflammation • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Psychopharmacology of Eugeroics-The Whole Nine Yards! (PubMed, Psychopharmacol Bull) - "Eugeroics are a distinct, yet heterogeneous group of psychotropic agents that differ from classical stimulants, are less activating, of less abuse potential, sorely clinically underutilized, and have an attractive pharmacological portfolio speaking to the idea of pluripotent molecules of an expanded therapeutic potential. Herein, authors would touch briefly on the current available literature on eugeroics as germane to psychiatric practice whilst examining the extant evidence."

Journal • Review • Psychiatry

Axsome Therapeutics Announces Settlement Resolving All SUNOSI (solriamfetol) Patent Litigation (GlobeNewswire) - "The litigations resulted from submission of Abbreviated New Drug Applications to the U.S. Food and Drug Administration by companies seeking approval to market a generic version of SUNOSI in the United States....As part of the resolution of these lawsuits, Axsome will grant five companies the right to sell generic versions of SUNOSI beginning on or after September 1, 2040, if pediatric exclusivity is granted for SUNOSI, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type."

Patent • Obstructive Sleep Apnea • Sleep Disorder

RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) (clinicaltrials.gov) - P2 | N=361 | Completed | Sponsor: Duke University | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Sleep Disorder

A validated Rhodamine B fluorescence quenching spectrofluorimetric method for solriamfetol determination in human plasma with pharmacokinetic application. (PubMed, RSC Adv) - "Finally, the method was successfully implemented for pharmacokinetic profiling in human volunteer plasma following administration of 75 mg solriamfetol, yielding t 1/2 = 7.6 h, C max = 465 ng mL-1, and t max = 1.5 h in agreement with literature values. This methodology offers significant advantages including visible-wavelength excitation minimizing matrix interference, rapid analysis time, and reduced environmental impact compared to conventional chromatographic techniques, thus providing a viable alternative for solriamfetol determination in therapeutic drug monitoring and pharmacokinetic profiling applications."

Journal • PK/PD data

Solriamfetol and CBT-I in Patients With Insomnia Disorder (clinicaltrials.gov) - P4 | N=115 | Completed | Sponsor: University of Pennsylvania | Active, not recruiting ➔ Completed | N=60 ➔ 115

Enrollment change • Trial completion • CNS Disorders • Fatigue • Insomnia • Sleep Disorder

TREATMENT PATTERNS AMONG PEOPLE NEWLY DIAGNOSED WITH NARCOLEPSY TYPE 1 IN THE UNITED STATES: A REAL-WORLD DATA STUDY (ISPOR 2026) - "Within 12 months of diagnosis, 87.2% (506/580) received narcolepsy-related treatments (NRTs: stimulants, antidepressants) or narcolepsy-indicated treatments (NITs: sodium oxybate, pitolisant, modafinil, armodafinil, and solriamfetol); 12.8% remained untreated. Findings indicate that treatment initiation is delayed after NT1 diagnosis, with frequent polypharmacy, switching, and high discontinuation rates within 12 months of diagnosis, highlighting substantial unmet treatment needs and the necessity for newer treatment options."

Clinical • Real-world • Real-world evidence • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Effects of Solriamfetol on Neuropsychological Outcomes in Patients With Obstructive Sleep Apnea in the Real-world SURWEY Study (AAN 2026) - "Epworth Sleepiness Scale scores improved by 4.7±2.7 (p<0.01); change in EDS was not associated with cognitive improvement (|r|=0.16, p=0.3). Conclusions In this observational study, solriamfetol reduced OSA-associated cognitive impairment, independently of improvements in EDS."

Clinical • Real-world • Real-world evidence • Alzheimer's Disease • Cognitive Disorders • Excessive Daytime Sleepiness • Narcolepsy • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder